MAUDE Adverse Event Report: ORGANON & CO. JADA SYSTEM; INTRAUTERINE VACUUM CONTRACTION SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information we have received, there is no indication that the device malfunctioned.The device is assembled according to specifications.In process and finished product testing are performed and approved prior to release.

Event Description

Initially the jada was working and controlling the bleeding, but then it clotted off [device occlusion] patient got hysterectomy and the bleeding was controlled [device ineffective] case narrative: this initial spontaneous report originating from the united states, was received from a physician and nurse via clinical account specialist referring to a 22-year-old female patient.The patient¿s current conditions included uterine atony.The patient¿s historical conditions included singleton pregnancy, bleeding, cesarean, fetal demise, and blood products transfusion (unknown volume).The patient¿s concomitant medications were not reported.This report concerned 1 patient and 1 device.On an unknown date in (b)(6) 2023 (reported as 1-2 weeks ago), the patient was started on vacuum-induced hemorrhage control system (jada system) (lot# and expiry date were not reported) (came with blue seal valve, kit and green carton) vaginally as directed by the health care professional (hcp) for postpartum hemorrhage (postpartum haemorrhage).The patient experienced device occlusion, device ineffective and device use error (captured in oars # (b)(4)).The device was operated by fellow, maternal fetal medicine and it may be first time for the operator.On an unknown date in (b)(6) 2023, the physician tried placing another vacuum-induced hemorrhage control system (jada system) (lot# and expiry date were not reported), but it also clotted off (also reported that the second one was used as the first one clotted off and was no longer sterile) (device occlusion).The patient then underwent hysterectomy and bleeding was controlled (device ineffective).The patient sought medical attention.Therapy with vacuum-induced hemorrhage control system (jada system) was discontinued.The availability of the vacuum-induced hemorrhage control system (jada system) for evaluation was unknown.Upon internal review, the event of device occlusion and device ineffective was determined to be serious: required intervention.This is one of the two reports received from the same reporter.When the lot number is unknown, a technical investigation of the specific manufacturing process which includes review of records associated with a known lot number cannot be performed.Medical device reporting criteria: serious injury.Fda code: (health effects health impact per annex f): 4624 surgical intervention (one or more surgical procedures was required, or an existing procedure changed.).

• Brand Name: JADA SYSTEM
• Type of Device: INTRAUTERINE VACUUM CONTRACTION SYSTEM
• Manufacturer (Section D): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer (Section G): ORGANON & CO.; 30 hudson street; jersey city NJ 07302
• Manufacturer Contact: 30 hudson street; jersey city, NJ 07302
• MDR Report Key: 16620179
• MDR Text Key: 312109429
• Report Number: 3002806821-2023-00032
• Device Sequence Number: 1
• Product Code: OQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K K201199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female